COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04529525

Rodrigo Zoni, Dr

rodrizoni@yahoo.com.ar

2020-08-27

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - over 18 years of age who reside in the province of corrientes at the time of diagnosis; - confirmed diagnosis of covid-19 by polymerase chain reaction test for detection of sars-cov2 in the last 48 hours; - in the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. a woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least one month before the time of inviting her to participate in this study); - weight at the time of inclusion greater than 48,000 kilograms; - that they sign the informed consent for participation in the study.

- pregnant or breastfeeding women; - known allergy to ivermectin or some of the components of ivermectin tablets or placebo; - current use of home oxygen; - that require hospitalization due to covid-19 at the time of diagnosis or history of hospitalization for covid-19; - presence of mal-absorptive syndrome; - presence of any other concomitant acute infectious disease; - known history of severe liver disease, for example liver cirrhosis; - need or use of antiviral drugs at the time of admission for another viral pathology other than covid-19; - need or use of hydroxychloroquine or chloroquine; - use of ivermectin up to 7 days prior to randomization; - patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months; - current participation or in the last 30 days in a research study that has included the administration of a drug.

2

Instituto de Cardiología de Corrientes

18

100

Argentina

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

501

Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]